Note: Descriptions are shown in the official language in which they were submitted.
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INTEGRATED SKELETAL IMPLANT AND ITS METHOD OF SURGICAL IMPLANTATION
Technical Field
[0001] The present invention relates to a device for osseointegration into a
patient.
Embodiments of the invention find specific, but not exclusive, use in the
provision and
installation of an osseointegrable component arranged to replace a portion of
a missing
femur bone in the leg of a patient. However, it will be understood that the
invention has
broader application.
Background Art
[0002] The following discussion of the background art is intended to
facilitate an
understanding of the present invention only.
The discussion is not an
acknowledgement or admission that any of the material referred to is or was
part of the
common general knowledge as at the priority date of the application.
[0003] Osseointegration is a technique which provides amputee patients with a
prosthetic implant which is integrated with the skeleton of a patient. That
is, an implant
where there is direct contact between living bone and the surface of a load
bearing
implant. Osseointegration dramatically enhances bone and joint replacement
surgery
by providing much stronger and longer lasting implants, which in turn provides
greater
quality of life for amputees.
[0004] In some currently utilised osseointegration implants, a skeletally
integrated
implant is connected through an opening in the stump of an amputee to an
external
prosthetic limb. This allows direct contact to the ground, which provides
greater
stability, more control and minimizes energy exerted.
[0005] As there is a direct connection between the implant and the external
prosthetic
limb, there is no need for a patient to use a so-called "suction" prosthesis.
Patients that
are unable to wear a suction prosthesis for long periods of time or those
confined to a
wheel chair may benefit from osseointegration implants. Indeed, bilateral
amputees
have been able to become mobile through osseointegration.
[0006] It is against this background that embodiments of the present invention
have
been developed.
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Summary of Invention
[0007] In a first aspect, the present invention provides an implant arranged
for
integration into a skeletal bone of a patient, comprising a body having at
least one end,
the body being arranged to substantially mimic a portion of a skeletal bone
and wherein
the at least one end includes a stepped portion arranged to, in use, prevent
migration of
the implant into the bone of the patient.
[0008] The width of the stepped portion may be greater than the width of the
body.
[0009] The at least one end may be arranged such that the at least one end
does not
substantially protrude from the skeletal bone.
[0010] The stepped portion of the at least one end preferably comprises a
coupling
portion arranged to, in use, receive a coupling part.
[0011] The coupling portion may further comprise a locking pin. The coupling
portion
may be tapered.
[0012] The body may include a coating arranged to assist osseointegration of
the
implant with the skeletal bone. In one embodiment, the coating includes a
porous
structure arranged to assist osseointegration of the implant with the skeletal
bone. The
porous structure may be formed from titanium, which may in turn be formed by a
plasma deposition process.
[0013] The implant may be sized to replace at least a portion of a human
femoral bone.
The implant may also have a curved shape, arranged to mimic the curve of a
human
femoral bone.
[0014] In one embodiment, the body of the implant further includes at least
one
projection which extends along a portion of the body, wherein the projection
is arranged
to, in use, prevent rotation of the implant relative to the skeletal bone. The
projection
may be at least one spline. The at least one spline may extend longitudinally
along the
body of the implant.
[0015] The implant may have a second end which is tapered.
[0016] A portion of the at least one end of the implant may be coated with a
physiologically inert substance. The physiologically inert substance may be
niobium.
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[0017] In another aspect, the present invention provides a surgical reaming
device
arranged for reaming a first space in skeletal bone to receive an implant
arranged for
integration into a skeletal bone of a patient, wherein the first space is
profiled to receive
an enlarged portion of the implant so that the enlarged portion does not
migrate into the
bone.
[0018] The reaming device may include a primary shaft that is arranged to
follow a
second space for receiving a portion of the implant, wherein the second space
is
profiled to be too small to receive the enlarged portion.
[0019] The primary shaft may be arranged to create the second space through a
drilling action.
[0020] The reaming device may include a tapered portion extending from a
portion of
the primary shaft, wherein the tapered portion is profiled to create the first
space.
[0021] The tapered portion may be truncated so as to create a stepped portion
at the
base of the first space.
[0022] The reaming device may include a textured portion of larger diameter
than the
primary shaft, wherein the textured portion is arranged to grind out the first
space.
[0023] The reaming device may include a collar at one end of the tapered
portion;
wherein the collar is arranged to control the depth of the first and second
spaces.
[0024] The collar may be profiled to be larger than an opening into the first
space.
[0025] The reaming device may be manually operated.
[0026] The reaming device may be operated by a powered device.
[0027] The powered device may be electrical or pneumatic.
[0028] In yet another aspect, the present invention provides a method of
surgically
implanting an implant into a skeletal bone of a patient, the method comprising
the steps
of:
forming a longitudinal cavity in the bone of the patient, the cavity being
arranged
to, in use, receive the implant;
wherein the cavity comprises at least one end;
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wherein the at least one end of the cavity further comprises a stepped portion
formed to substantially mimic the shape of the implant; and
implanting the implant into the cavity.
[0029] The longitudinal cavity may be formed by the primary shaft of the
reaming
device.
[0030] The stepped portion may be formed by the tapered portion.
[0031] In yet another aspect, the present invention provides a method of
surgically
preparing a skeletal bone of a patient for receiving an implant, the method
comprising
the step of forming a longitudinal cavity in the bone of the patient, the
cavity comprising
at least one end, the cavity arranged to, in use, receive the implant, wherein
the at least
one end of the cavity further comprises a stepped portion formed to
substantially mimic
the shape of the implant.
[0032] The method may include the step of, prior to forming a longitudinal
cavity,
inserting an end of the skeletal bone for receiving the implant into a
clamping device
and restraining it with the clamping device.
[0033] The bone may be restrained between a first and a second receiving jaw.
[0034] The first and second receiving jaws may be arranged to come together
and
restrain the bone in a compression clamping arrangement.
[0035] The first and second restraining jaws may be located within a central
portion of
the clamping device.
[0036] A removable bucket may be attachable to the clamping device to collect
material removed from the skeletal bone.
[0037] A front face of the clamping device may be arranged to form a guide for
sawing
the skeletal bone.
[0038] In yet a further aspect, the present invention provides a clamping
device for
restraining skeletal bone in inserting an implant arranged for integration
into a skeletal
bone of a patient, including a central portion arranged to receive the
skeletal bone and
first and second receiving jaws within the central portion arranged to exert a
compression clamping force on the skeletal bone.
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[0039] At least one of the first and second receiving jaws may be movable with
respect
to the other through a screwing action to exert the compression clamping
force.
[0040] Handles may be attached to the first and second receiving jaws.
[0041] A front face of the clamping device may be arranged to form a guide for
sawing
the skeletal bone.
[0042] The clamping device may include a removable bucket to collect material
removed from the skeletal bone.
Brief Description of the Drawings
[0043] Further features of the present invention are more fully described in
the
following description of several non-limiting embodiments thereof. This
description is
included solely for the purposes of exemplifying the present invention. It
should not be
understood as a restriction on the broad summary, disclosure or description of
the
invention as set out above. The description will be made with reference to the
accompanying drawings in which:
Figure 1 is a side view of an osseointegrative implant in accordance with an
embodiment of the present invention;
Figure 2 is a projected view of an osseointegrative implant in accordance with
an embodiment of the present invention;
Figure 3 is a side view of an osseintegrative implant in accordance with an
embodiment of the present invention, when implanted in a femur bone;
Figures 4A to 4C are side, perspective and projected views of a first coupling
part arranged to couple at one end with the osseointegrative implant in
accordance with
an embodiment of the invention and at the other end with a prosthetic;
Figure 5 is a perspective view of a reamer for creating a space in skeletal
bone
in accordance an embodiment of the present invention;
Figure 6 is a perspective view of a reamer for creating a space in skeletal
bone
in accordance an embodiment of the present invention;
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Figure 7 is a side view of a reamer for creating a space in skeletal bone in
accordance an embodiment of the present invention when reaming a space in a
femur
bone;
Figure 8 is a side view of an osseointegrative implant in accordance with an
embodiment of the present invention, when implanted in a femur bone;
Figure 9 is a side view of a passageway formed in a bone to receive an
osseointegrative implant in accordance with an embodiment of the present
invention;
Figure 10 is a perspective view of a clamping device in accordance with an
embodiment of the present invention;
Figure 11 is a perspective view of a clamping device in accordance with an
embodiment of the present invention;
Figure 12 is a perspective view of a clamping device in accordance with an
embodiment of the present invention;
Figure 13 is a perspective view of a clamping device in accordance with an
embodiment of the present invention;
Figure 14 is a perspective view of a clamping device in accordance with an
embodiment of the present invention; and
Figure 15 is an exploded view of a first coupling part arranged to couple at
one
end with the osseointegrative implant in accordance with an embodiment of the
present
invention.
Description of Embodiments
[0044] Broadly, embodiments of the invention relate to an implant arranged for
integration into a skeletal bone of a patient. Such implants are generally
referred to as
"osseointegrative"implants.
[0045] In the ensuing description, like reference numerals in consecutive
figures refer
to like or functionally identical parts.
[0046] The embodiment described herein, with reference to Figures 1 through 3,
an
implant 100 which comprises a body 102 having at least one end 104. The body
102 is
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elongate as it is arranged to substantially mimic a portion of a skeletal
bone. In the
embodiment described herein, the implant 100 is designed to be implanted in
the leg of
a patient, as a partial replacement for the femur bone of a patient. The
patient is an
amputee who is seeking to use a prosthetic limb and requires the implant to
serve as an
"attachment" point for the prosthetic limb.
[0047] The at least one end 104 which includes a stepped portion 106 arranged
to, in
use, prevent migration of the implant into the bone of a patient.
Osseointegrative
implants suffer from the issue of the 'end' of the implant, which is
necessarily open to
the air and passes through the flesh and skin of a patient, being slowly
'pushed
upwards' (i.e. upwardly migrating) when the patient wears a prosthetic limb
which exerts
upward pressure on the implant and therefore can cause the end of the implant
to
migrate into the bone of the leg of the patient. The embodiment described
herein, in
contrast, utilizes a stepped portion 106 to prevent such 'upward migration' of
the implant
into the leg of the patient.
[0048] At least part of the stepped portion 106 is covered by a
physiologically inert
substance, to reduce the possibility of infection or an immune reaction at the
site at
which the implant 100 contacts the flesh of the patient's leg. In the
embodiment
described herein, the physiologically inert substance is niobium, but it will
be understood
that other coatings may be used, such as gold, or any other coating known or
discovered to be physiologically inert. Such variations are within the purview
of a
person skilled in the art.
[0049] The at least one end 104 of the implant 100 further includes a coupling
part 107
which is arranged to receive a coupling portion (which will be described in
more detail
later).
[0050] In addition to the stepped portion 106 having a coating, at least a
portion of the
body 102 may also have a coating (generally denoted by 108), which has the
purpose
of assisting the implant 100 to integrate into the skeletal bone 110.
[0051] In one embodiment, the coating is a suitable porous structure which
assists in
encouraging bone growth into the porous structure, thereby assisting
osseointegration
of the implant into the skeletal bone. In one embodiment, the porous structure
is formed
from titanium which is deposited on the surface of the body 102 by using a
plasma
deposition process.
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[0052] The implant has a curved shape which is generally visible at area 112,
which is
arranged to mimic the curve of a human femoral bone. It will be understood
that
different types of implants may have different shapes and profiles, as may be
required
to meet certain skeletal and anatomical constraints. Such variations are
within the
purview of a person skilled in the art.
[0053] The body 102 of the implant 100 further includes at least one
projection 114
which extends along a portion of the body 102. The projection is arranged to,
in use,
prevent rotation of the implant relative to the skeletal bone, by providing
'grip' to prevent
rotation of the implant 100 when it is located inside the skeletal bone.
In the
embodiment shown in the Figures, the projection 114 is at least one spline
which
extends longitudinally along the body of the implant. However, it will be
understood that
other variations which achieve the same functionality may include the
provision of
raised patterns (a `zig-zag' pattern), circumferential ridges, or other simple
or complex
patterns.
[0054] The implant 100 also has a second end 116 which is tapered, to allow
the
patient to also receive an artificial hip implant (or other implant) which can
be attached
to the leg implant.
[0055] Referring now to Figures 4A to 4C there is shown a coupling part which
is
arranged to cooperate with the implant 100. The coupling part 200 includes a
locking
slot 202 arranged to lockingly slot into the implant 100. The coupling part
also includes
a connector engagement boss 204 arranged to connect, either directly or
indirectly, with
a prosthetic device (not shown), in cooperation with a locking pin channel
206, which is
arranged to receive a pin (not shown) to lock the prosthetic (not shown) to
the coupling
part 200.
[0056] Of course, it will be understood that the implant 100 may be
manufactured in
different sizes, so that the correct size may be provided for different
patients of different
heights, weights and builds. This may include manufacturing implants of
different
lengths and/or implants which have different radial profiles. Such variations
are
encompassed by the broader inventive concept described and defined herein.
[0057] Referring now to Figures 5, 6 and 7 there is shown a reaming
device/tool 11, 20
for creating a first space in the skeletal bone to receive the stepped portion
106 of the
implant 100. The first space is profiled so that the stepped portion 106 rests
against
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bone when inserted in place in the first space so that the stepped portion 106
is
restrained by the bone it rests against and does not migrate further into the
bone.
[0058] In one embodiment a small reamer (not illustrated), longer than reaming
tool 11,
20 is used prior to reaming tool 11, 20. The small reamer is used on skeletal
bone to
drill into the medullary cavity of the bone creating passageway 25.
[0059] In an alternative embodiment, the primary shaft 17 of the reaming tool
11 is
used to drill into the medullary cavity to form passageway 25 by reaming it
out.
[0060] With reference to Figure 5, a reaming tool 11 for creating the first
space in
accordance with an embodiment of the present invention is shown. The reaming
tool 11
includes primary shaft 17 with leading end 18 that is arranged and profiled to
be
inserted into passageway 25. Attachment coupling 13 is located at an opposite
end to
leading end 18 and is connectable to a manual or powered tool to rotate the
reaming
tool 11. Truncated taper portions 19 are arranged as fluting along a portion
of the
primary shaft 17, distal the leading end 18.
[0061] The truncated taper portions 19 include stepped ends 21 to create the
truncation of the taper portions 19. When the reaming tool 11 is rotated,
either manually
or in a powered fashion, and the primary shaft 17 is entered into passageway
25 so that
truncated taper portion 19 engages skeletal bone a first space is created that
has a
stepped base corresponding to stepped ends 21 and tapered sides corresponding
to
the taper of the truncated taper portion 19. The first space is sized to
correspond to the
size of the stepped portion 106 of the implant 100.
[0062] A collar 15 is located at the end of the truncated taper portions 19
distal to the
primary end 18. The collar 15 extends out from the primary shaft 17 in a
generally
perpendicular fashion. The collar extends perpendicularly outward further than
the
truncated taper portion 19. This ensures that the collar 15 extends beyond the
perimeter of the first space so that the collar cannot enter the first space
or into the
skeletal bone. Therefore, the collar 15 defines the maximum depth of the first
space to
be the distance between the stepped ends 21 and the collar 15 as it limits the
insertion
of the reaming tool 11.
[0063] Referring to Figure 6, an alternative reaming tool 20 for creating the
first space
in accordance with an embodiment of the present invention is shown. Features
of the
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reaming tool 20 that correspond to those of Figure 5 have been given the same
numbering.
[0064] Instead of having truncated taper portions 19, the reaming tool 20
includes
tapered portions 23 arranged as fluting that taper all the way onto the
surface of the
primary shaft 17. When the reaming tool 20 is operated, spinning to perform
its reaming
function, the tapered portions 23 create a first space in the skeletal bone
that is entirely
tapered. The stepped portion 106 of the implant 100 is larger at its top than
its bottom
and therefore is held in the first space so that it cannot migrate into the
skeletal bone to
which it is attached.
[0065] The skilled addressee will recognize that the truncated taper portions
19 or
tapered portions 23 could be replaced with alternative reaming structures
designed to
create a first space larger than passageway 25. For example a grinding block
of a
larger cross sectional profile than the primary shaft 17, with a textured
outer surface
could be used to create the first space.
[0066] The truncated taper portions 19 or tapered portions 23 could be
distinct
components to the primary shaft, and could for example be attached to the
primary
shaft 17 and still fall within the scope of the present invention.
[0067] Referring to Figure 7, the reaming tool 11 is illustrated fully
inserted into the
skeletal bone.
[0068] Referring to Figure 8, the implant 100 is shown inserted in the
skeletal bone 110
with the truncated tapered portion inserted into the first space.
[0069] Referring to Figures 10 to 14 a clamping device 31 is illustrated for
holding the
skeletal bone 110 in place when surgery is undertaken for inserting the
implant 100 into
a patient.
[0070] The clamping device 31 includes central portion 32 in which the
skeletal bone is
to be received and restrained. The central portion 32 includes an internal
space 34 that
is of a size and shape to allow enlarged portions of a bone, such as the
epiphysis
regions, or metaphysis or diaphysis regions of different sizes, to pass though
the
internal space 34. Within the spaced region 34 are a first receiving jaw 37
and a
second receiving jaw 39 between which a metaphysis or diaphysis region of the
skeletal
bone 110 can be held in a compression clamping fashion. Both the first and
second
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receiving jaws 37, 39 have a generally semi-circular profile with teeth 41
along the semi
circular profile. The generally semi-circular profile of the first and second
receiving jaws
37, 39 allow skeletal bones 110 with different metaphysis or diaphysis
diameters to be
restrained within the clamping device 31. The front face 61 of the central
portion and fist
and second receiving jaws 37, 39 is flat.
[0071] The first receiving jaw 37 is fixed in place within the central portion
32 and
internal space 34. Connected to the first receiving jaw 37 is first handle 43.
The first
handle 43 extends outwards from the central portion 32 so that a user can grip
the
handle to aid positioning the central portion 32 and first and second
receiving jaws 37
around the skeletal bone 110.
[0072] The second receiving jaw 39 can be moved within the internal space 34
to
increase and decrease the distance between it and the first receiving jaw 37.
A second
handle 45 is connected to the second receiving jaw 39 and extends outwards
from the
central portion 32. The second handle 45 includes a male threaded portion 47
that is
connected to a first female threaded portion (not shown) in the second
receiving jaw 39
and a second female threaded portion 49 in the central portion 32. The
threaded
engagement between the male threaded portion 47 and the first and second 49
female
threaded portions allow the distance between the first and second receiving
jaws 37, 39
to be increased or decreased manually through rotation of the second handle
45.
[0073] In one embodiment of the present invention both the first receiving jaw
37 and
the second receiving jaw 39 can be moved with respect to each other to
increase or
decrease the distance between them.
[0074] In one embodiment of the present invention the second receiving jaw 39,
or
both the first and second receiving jaws 37, 39 can be moved with respect to
each other
to increase or decrease the distance between them by using a hydraulic,
pneumatic or
electric actuator.
[0075] To clamp the skeletal bone 110 in place, a metaphysis or diaphysis
region of
the skeletal bone is placed between the first and second receiving jaws 37, 39
and the
two are moved together to clamp the clamping device to the skeletal bone 110
with a
compression clamping action.
[0076] A bucket 53 is removable attachable to the base of the central portion
32 to
receive material that is discharged from the skeletal bone 110. The bucket
includes
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studs 51 that are arranged to be received in recesses 51 in the base of the
central
portion 32 in a press stud fastening manner. The studs 51 are located on one
side of
the opening 55 of the bucket so that discharge from the skeletal bone 110 will
drop into
the bucket.
[0077] The skilled addressee will recognize that alternative fastening means
can be
used to attach the bucket 53 to the central portion 32 such as threaded
engagement,
clamping engagement or otherwise.
[0078] A sieve 53 is insertable into the bucket to capture thicker material
such as bone
marrow, bone shards or otherwise.
[0079] A female threaded portion 57 is located in the top surface of the
central portion
32. The threaded female portion can receive an addition handle portion (not
shown) to
assist in manipulation of the clamping device 31.
Method of Installing Implant
[0080] The following method of installing the implant 100 will be described
with respect
to a femur. The skilled addressee will readily recognize that the method
applies to other
skeletal bones of the body where osseointegrative implants can be used and
bone
depth allows for a first space and smaller passageway 25. The method will also
be
described with reference to the reaming tool 11. It will be understood that
the reaming
tool 21 can readily replace the reaming tool 11 for the following method.
[0081] The region of the skeletal bone 110 where the implant 100 is to be
inserted is
exposed. The metaphysis, diaphysis or epiphysis region at the end of the
implant
region is passed through the central portion 32 of the clamping device 31. The
first and
second receiving jaws 37, 39 are arranged around the region of the skeletal
bone 110
where the implant is to be inserted.
[0082] The second receiving jaw 39 is moved closer to the first receiving jaw
37
through rotating the second handle 45. The first and second receiving jaws 37,
39
come together and through teeth 41 exert a compression clamping force on the
skeletal
bone 110.
[0083] With the clamp 31 in place, the portion of skeletal bone 110 extending
beyond
the clamp 31 is sawn off. The flat front face 61 of the central portion 32 and
first and
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second receiving jaws 37, 39 provide a guide for the sawing that results in an
accurate,
straight cut through the bone.
[0084] The cut off bone falls into the bucket 53. Broaching is performed on
the
medullary cavity of the skeletal bone 110 to create the passageway 25 of
sufficient
diameter to receive the body 102 of the implant 110. During the broaching
activity, the
bone and marrow extracted is collected in the bucket 53.
[0085] Alternatively, a small reamer, either mechanical or powered, is drilled
into the
medullary cavity of the femur along its length to create passageway 25.
[0086] The reaming tool 11 has its attachment coupling 13 connected to a
manual or
powered rotation source. The primary end 18 of the primary shaft 17 is
inserted into the
created passageway 25 and the stepped ends 21 of the truncated tapered portion
19
are engaged with the end of the femur adjacent the created passageway 25 and
operated to ream out bone from the end portion of the femur. The rotation of
the
truncated tapered portion 19 and pressure applied to the reaming tool 11 reams
out
bone from the femur. Reaming of bone to form the first space is limited to a
depth
defined by the collar 15. When the collar 15 abuts the end of the femur to
which the
reaming tool 11 is applied, the primary shaft 17 and truncated tapered portion
19 can
enter the femur no further and the first space has been created, defined by
the shape of
the truncated tapered portion 19. The reaming tool 11 is then removed from the
femur
and implant 100 is inserted into the femur so that body 102 is placed into
passageway
25.
[0087] As the reaming is performed, bone material removed by the creation of
the first
space is collected in the bucket 53. The bone collected form the broaching and
reaming
is inserted into the medullary cavity where the implant 100 is inserted to
assist with
bonding.
[0088] Stepped portion 106 of the implant 100 is placed into the first space
created by
the truncated tapered portion 19. As the stepped portion 106 has a cross
section larger
than passageway 25, the implant is restrained from migrating into the femur
where the
stepped portion abuts the base of the first space.
Advantages and Industrial Applicability
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[0089] One of the advantages of the embodiments and broader invention
described
herein is that the invention has a stepped portion arranged to stop upward
migration of
the implant into the bone of the patient.
[0090] The implant also preferably includes a porous coating, such as a plasma
titanium spray, which acts to induce and assist osseointegration.
[0091] Lastly, the embodiment is tapered on the proximal end to allow for
future hip
implants that may be required by the patient.
Disclaimers
[0092] Throughout this specification, unless the context requires otherwise,
the word
"comprise" or variations such as "comprises" or "comprising", will be
understood to
imply the inclusion of a stated integer or group of integers but not the
exclusion of any
other integer or group of integers.
[0093] Those skilled in the art will appreciate that the invention described
herein is
susceptible to variations and modifications other than those specifically
described. The
invention includes all such variation and modifications. The invention also
includes all
of the features referred to or indicated in the specification, individually or
collectively and
any and all combinations or any two or more of the steps or features.
[0094] Other definitions for selected terms used herein may be found within
the
detailed description of the invention and apply throughout. Unless otherwise
defined, all
other scientific, medical, engineering and technical terms used herein have
the same
meaning as commonly understood to one of ordinary skill in the art to which
the
invention belongs.
